Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy

NCT07885033 | Not Yet Recruiting

• 1 other identifier: OSEM-PREMIER-PROSP-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

People having radiation therapy to the head and neck often develop painful mouth problems - mouth sores, dry mouth, mouth pain, trouble eating and drinking, and changes in taste. These problems can become severe enough to interrupt radiation treatment or lead to an emergency room visit or a hospital stay. This study is testing whether an oral care program called OSEM (Oral Side-Effect Management) reduces how severe those mouth problems become. Fifty adults starting radiation to a head and neck site at Premier Cancer Center will take part. Each person will be assigned by chance, like a coin toss, to one of two groups: One group receives the Peace of Mouth Kit - everyday mouth care products including dry mouth candies, ginger candies for nausea, a mouth rinse, a sensitivity toothpaste, a soft toothbrush and a lip balm - together with a short check-in each week with a member of the Premier team right after their radiation treatment. The other group receives their usual care at Premier, unchanged. Everyone in the study fills out the same short questionnaire about their mouth each week during radiation, and once more about four weeks after their last treatment. Everyone continues to see their radiation doctor every week, exactly as they would if they were not in the study. Taking part lasts about 11 weeks in all. The items in the kit are everyday consumer mouth care products. They are not medicines of any kind, and the U.S. Food and Drug Administration has not approved them to treat or prevent any disease.

Conditions

Head and Neck Cancer (H&N); Stomatitis (Oral Mucositis); Oral Mucositis (Ulcerative) Due to Radiation; Xerostomia Due to Radiotherapy; Radiation Toxicity

Keywords

oncology side-effect management pilot study

Outcome Measures

Primary Outcomes (1)

• Oral symptom burden: area under the weekly oral symptom score curve

  The weekly oral symptom score is the sum of eight patient-reported oral symptom domains - mouth pain, mouth sores, dry mouth, dry or chapped lips, taste changes, trouble eating or drinking, nausea when eating or drinking, and dizziness or dark urine - each graded on a four-level scored severity collapse. The score ranges from 0 to 42, where a higher score indicates greater symptom burden. Area under the curve is computed by the trapezoidal rule across available weekly assessments and standardized for the number of assessments contributed, so that participants with different course lengths are comparable. A lower area under the curve indicates lower symptom burden across the radiation course.

  From the first delivered radiation fraction (Time 0) through the end-of-treatment assessment, up to 7 weeks and the a 4 week end of trial follow up.

Secondary Outcomes (8)

• Peak oral symptom severity

  From Time 0 through the end-of-treatment assessment, up to 7 weeks and then a final follow up 4 weeks later

• Time to first moderate or worse oral symptom

  From Time 0 through the end-of-treatment assessment, up to 7 weeks and then a final follow up 4 weeks later

• Proportion of participants reaching severe or very severe oral symptom severity

  From Time 0 through the end-of-treatment assessment, up to 7 weeks and then a final follow up 4 weeks later

• Unplanned acute-care use attributable to oral toxicity

  From Time 0 through the follow-up assessment 4 weeks after the final radiation fraction, up to 11 weeks

• Unplanned radiation treatment interruption attributable to oral toxicity

  From Time 0 through the final radiation fraction, up to 7 weeks

Other Outcomes (4)

• ePRO completion rate

  From Time 0 through the follow-up assessment, up to 11 weeks

• Clinical coordinator weekly review completion rate

  From Time 0 through the final radiation fraction, up to 7 weeks

• Time from Stage 2 band review to escalation contact

  From Time 0 through the final radiation fraction, up to 7 weeks

Study Arms (2)

OSEM Program

EXPERIMENTAL

Participants receive the Peace of Mouth Kit at enrollment, at approximately week 5, and at the final treatment visit in week 7 - three kits in total - together with a structured review by the Premier clinical coordinator each week, immediately after radiation treatment. The weekly review consists of a fixed set of safety-flag questions, review of the participant's weekly symptom band and red-flag status, and assessment of kit use. Where the band or a red-flag criterion indicates it, the coordinator escalates directly to the on-call Premier radiation oncologist, who determines clinical management. The study does not direct clinical management. Premier standard of care continues unchanged, including the weekly radiation oncologist assessment and the after-hours on-call service.

Other: ORAL CARE PRODUCT KIT

STANDARD OF CARE

NO INTERVENTION

Participants receive Premier standard of care without modification, including the weekly radiation oncologist assessment, the after-hours on-call service, and any supportive-care measure the treating team judges appropriate. Participants complete the same baseline and weekly symptom questionnaire as the intervention arm, for research purposes only. The resulting symptom band is computed and retained for analysis but is not reviewed for escalation, is not returned to anyone, and does not generate any contact. There is no kit, no clinical coordinator review and no safety-flag questions. Kit components and equivalent products remain commercially available, and nothing is withheld from participants in this arm.

Interventions

ORAL CARE PRODUCT KIT OTHER

A kit of six commercially available consumer oral care products, supplied at enrollment, at approximately week 5, and at the final treatment visit in week 7 - three kits in total, each a one-month supply. Each kit contains: dry mouth candies, 6 packs, xylitol-based, 3 lemon and 3 sour cherry; nausea candies, 1 pack, ginger, xylitol-based; soothing mouth rinse, 30 single-dose stick packs of sodium chloride and sodium bicarbonate, one per day; sensitivity toothpaste with 10% nano-hydroxyapatite and xylitol, 3 oz; a soft bamboo-handled toothbrush; and a lip balm. A reusable bottle for preparing the daily rinse comes with the first kit only. Use is at the participant's discretion, following written instructions in each kit. Participants may stop any component at any time and are told to do so if it causes discomfort. No component is a prescription or over-the-counter drug, and none is FDA-approved to treat or prevent any disease.

Also known as: OC ORAL CARE KIT, PEACE OF MOUTH KIT

OSEM Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older Histologically confirmed malignancy of a head and neck site Planned definitive or post-operative external beam radiation therapy to a head and neck site, delivered at Premier Cancer Center Planned course of at least 20 fractions over approximately 4 to 7 weeks With or without concurrent systemic therapy Able to provide written informed consent Able to complete an electronic questionnaire in English, with or without assistance

You may not qualify if:

• Palliative short-course radiation, or a planned course of fewer than 20 fractions Re-irradiation of a previously irradiated head and neck field Radiation delivered at an institution other than Premier Known allergy or sensitivity to any component of the Peace of Mouth Kit Any condition that, in the judgment of the treating radiation oncologist or the Premier Physician of Record, makes participation unsafe or impracticable Inability to complete study assessments

Sponsors & Collaborators

• UNCANCER LLC: lead
• PREMIER CANCER CENTER: collaborator

Study Sites (1)

Premier Cancer Center

Clearwater, Florida, 33765-1703, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis; Ulcer; Radiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• ABIDA TAHER

  UNCANCER LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ABIDA TAHER, MD PHD

CONTACT

8328602812; abida@uncancer.com

ROBYN LESSER, DMD

CONTACT

813-786-3831; robyn@uncancer.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 12 months after publication of the primary results and ending 5 years after publication.
• Access Criteria: Who: qualified researchers with a methodologically sound proposal and a stated analytic purpose. What: the de-identified participant-level dataset supporting the published results, the Statistical Analysis Plan, the analysis code, and the frozen OSEM model specification with its build identifier and cryptographic hashes, so that any published score can be independently reconstructed. How: requests are submitted in writing to the study office and are reviewed by the Principal Investigator and the study biostatistician. A data use agreement must be executed before any transfer, under which the requester agrees not to attempt re-identification of participants and not to transfer the data to third parties. Release is subject to the de-identification standard applied to the dataset and to any restriction in the executed site and sponsor agreements.

Locations

US (1)